• International Journal of Internet, Broadcasting and Communication
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• v.13 no.1
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• pp.1-10
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• 2021

The type approval system for railway vehicle has been in effect since 2016 in order to establish a regular safety management system to secure railway safety and enhance the technological competitiveness of the railway industry, abolished the conventional performance test system through the reform of the Railroad Safety Act in 2012. Until now, there has been appreciated it has been making significant contributions to railway safety and industry of operation and manufacturing companies, taking their place in accordance with the implementation of the system. But there has been no case of quantitative analysis on the effectiveness of the actual system. In this study, in order to examine the full-scale performance of the approval system and quantitatively analyze effectiveness, we identified and defined the relationships with the major elements of the type approval system based on system thinking principle and determined the calculated outcomes to relevant stakeholders. A method of establishing a type approval performance management system that can be grasped, utilized, and adjusted from a point of various stakeholders' views was proposed. This is expected to be more helpful in the implementation of the system, such as improving and applying quantitative effects to analysis by closely reviewing the effects and influencing factors of the type approval system based on the data accumulated through continuous performance management and reflecting to system improvement.

• Journal of the Korean Institute of Navigation
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• v.19 no.4
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• pp.63-82
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• 1995

This paper is a study on standard testing method for type approval of DSC which is the main structure of the terrestrial communication. As authority inspecting offices and producers have no experience for type approval of relative equipments as adapting GMDSS. In this paper, it is to be improved the understanding for type approval ; a system, standard of technic and testing methods, etc and make better quality of relative equipments. Additionally it could help quality and quantity improvement in all radiocommunication parts. Of course, the regulation for type approval had made but most makers didn't know it correctly, so the method of solution have been studied. By result of this study, with comparision and analysis of structure and a condition of efficiency with adapting GMDSS is could help some problems slove in the field and gave testing method of machinery and tools, electrical conditions, came out measurement and did ways standard efficiency.

• Proceedings of the Korea Committee for Ocean Resources and Engineering Conference
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• 2001.10a
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• pp.15-19
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• 2001

Electronic navigation system onboard have have been developed with recent technology based on new concept such as electronic chart date. The most valuable system of revolution in electronic navigation equipment is ECDIS, which have been developed in order to reduce work load of mariner and give an integrated information by simple means, especially to improve the safety of ship's navigation. In order to be sure the function of ECDIS is satisfied, The international standard have regulated the performance in the standard, so ECDIS should be type approved by the marine equipment authority of each government. There are three basic documents, IEC61174, IEC61162, IEC60945 issued by IMO(International Maritime Organization) which should be used for type approval system of each authority. IEC 61174 include the method of test and required results for operational and functional performance of test equipment. IEC61162 is for sensor interface and IEC60945 is related to the test of environmental condition for general marine radiocommunication equipment. In this paper, we investigate international standard in detail and current approval system of general marine equipment. After that, we present the possible structure of type approval of ECDIS and important considerations of approval system such that ECDIS should be tested as one system not be separated between S/W and H/W.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.22 no.2
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• pp.225-240
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• 1997

With the lanuch of the World Trade Organization(WTO) system, National and international trends toward more liberalized regulation of telecommunications terminal equipments drive the globalization of the telecommunications market. Despite of such trends, most countries have long viewed the type approval system as a major hindrance to overseas maketing because of a hodgepodge of diverse type approval system of telecommunications terminal equipments in each country. But, recently, many countries under these situations try to make a better understanding of respective requeirements of each country's many countries under these situations try to make a better understanding of respective requirements of each country'stype approval system, and where possible to strengthen commonalities, through referred to as "multual recognitio" system for the purpose of the development of procedures for hamonization oftype approval system in "one world, one market". Thus, this paper covers the definition, considerations and the case studies of mutual recognition between countries. Also, this paper suggests the desirable and general model of mutual recognition to be applied all the countries, which are being preparing and processing it.g and processing it.

• Proceedings of the Korean Society of Precision Engineering Conference
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• 2013.05a
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• pp.1603-1604
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• 2013

• Journal of Auto-vehicle Safety Association
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• v.14 no.4
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• pp.106-112
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• 2022

The purpose of this study is to explore ways of improving the motor vehicles safety certification system in preparation for the deployment of Lv.4 or higher autonomous vehicles. In order to effectively achieve the objectives of this study, theoretical and empirical research methodologies were employed, including literature review of prior research, government-published data, etc.; comparative research on legislative cases of other countries regarding motor vehicles safety certification; historical and legal research on domestic systems; legal analysis to explore approaches for improvement, etc. Some argue that the type approval system is needed in preparation for deploying autonomous vehicles, but there are several limitations in moving to the type approval system from the self-certification system currently adopted in Korea. First, there is a possibility that the system may be in conflict with the Korea-U.S. MOU regarding Foreign Motor Vehicles (1988) and the Korea-U.S. FTA (2011); second, there is a risk of undermining the cause of the self-certification system, which is the autonomy of manufacturers; third, the boundary between autonomous vehicles and non-autonomous vehicles is unclear; and fourth, the type approval system may hinder technological competitiveness. On the other hand, considering that the Korea-U.S. FTA and the UNECE IWVTA recognize exceptions to deal with road safety and risks to human health or the environment, and have a pre-certification system for some auto parts such as pressure-resistant containers, it can be said that there is room to introduce the type approval system for supplementation purposes. To improve the motor vehicles safety certification system while ensuring the safety of autonomous vehicles of Lv.4 or higher, the targets of type approval should be defined and the criteria, procedures, etc. for type approval should be established. At the same time, the consistency between motor vehicle-related laws and harmonization with international standards need to be considered.

• Journal of Pharmaceutical Investigation
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• v.36 no.6
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• Proceedings of the Korean Society of Marine Engineers Conference
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• 2011.06a
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• pp.250-253
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• 2011

The cruise industry is one of the world's fastest growing device industry which is structural construction coasts are expensive. Cruise out-fittings are thirty times compare with general large vessels. According to the characteristics of materials or equipments, most equipments are imported from europe. At present domestic shipbuilding industries and minor enterprises have a hard times therefore enhancing technology for the cruise industry could be infused vitality on the industries. If domestic small and midium industries have high technology for the cruise ship, domestic small and midium industries can have global competitiveness compare with european equipment suppliers which has small-scale and high technology. Therefore on this study, cruise ship's new equipment development and a study for the performance assessment and classification type approval certificate was carried out.

• Proceedings of the Korean Institute of Navigation and Port Research Conference
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• 2004.04a
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• pp.269-274
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• 2004

The marine electronic system for safe navigation such as ECDIS has been contributing to increase the safety of navigation, decreasing the mariner's load of navigation. The ECDIS should be developed and approved by international standard of IMO for performance standard and IEC for type-approval method and required results. However, these standards have some ambiguities for us not to directly adopt them for real approval system, so we should analyze them for more clear meaning and prepare our own detail standard for type-approval system. The first thing to do for the goal of this research was to analyze the standard in detail and make ambiguity be cleared in our own standards, considering each test item in view of test methodology. For the result of analysis we could develop more evident and detail type-approval standard for each test item with test technology needed. Especially, we developed the colour differentiation test process of ECDIS monitor, which include the colour differentiation formula derived from CIE colour scheme. Several test items require sensor informations of navigation equipment compatible with IEC 61162. We also developed the signal simulator for general messages of IEC 61162 that must be provided. Additionally, the type-approval processes and standards for Back-up arrangement and RCDS mode were developed.

• Journal of the Korea Institute of Information Security & Cryptology
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• v.32 no.2
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• pp.279-287
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• 2022

With the advancement of cyber threats and the development of hacking technologies, cyber security is being emphasized in various fields such as automobiles and ships. According to this trend, various industrial fields are demanding cybersecurity, and related certifications. In this paper, cybersecurity type approval is compared with the RMF stage under the premise that there are common elements with RMF in that cybersecurity elements must be reflected in the entire system development cycle. For comparison, type approval of maritime cyber security of the Korean Register of Shipping was selected. In conclusion, although type approval of maritime cyber security acquisition procedure is not divided by development stage like the RMF, there are the commonalities in the procedure to apply the cybersecurity element to the System development lifecycle like the RMF. Accordingly, the possibility of determining that the cybersecurity element was applied to the entire development cycle was confirmed.